1. Fields of Invention
The present invention relates generally to a device used with a colon hydrotherapy speculum system, and, more particularly, relates to a dissolvable tip that is used with the speculum of a colon hydrotherapy system that provides colonic lavage.
2. Discussion Of Background And Prior Art
A number of people have difficulty with their bowel movements or do not have the ability to voluntarily evacuate their bowels (i.e. especially the elderly and the handicapped). Other people suffer from colitis or other related colon, rectal, or bowel ailments or diseases, which require ravaging or washing of the lower intestinal tract (i.e. the colon or rectal areas). In these cases, the people have to regularly use an enema, manually remove the fecal matter, or use a colonic irrigation or lavaging system.
The problems with colonic irrigation or lavaging systems are that the insertion of the nozzles or speculum of these devices can be very uncomfortable, unsanitary (i.e. including but not limited to fecal matter involuntarily excreting from the patient), and the lavage fluid motion produced by these systems may not be effective in loosening up and purging the fecal matter. In order to facilitate insertion of the speculum in the patient's rectal or anal canal and alleviate some of the discomfort, an obturator is used in conjunction with the speculum. FIGS. 1 and 2 show a prior art speculum 10 and an obturator 25. The speculum 10 has a main tubular portion 15 having a hollow interior 19, a small inlet tube 16 intersecting the main tubular portion 15 so that inlet fluids can be introduced into the speculum an inlet end 17, and an outlet end 18. The obturator 25 has an elongated rod 26, a rounded tapered end 27, and a small handle portion 28.
The obturator 25 is inserted through an end 18 of the speculum 10, through hollow interior 19 to extend through the end 17. The rounded tapered end 27 facilitates insertion of the speculum 10 into the patient's rectum or colon area (i.e. via the anal canal). After the speculum 10 is inserted, the obturator 25 is then removed from the speculum 10 by using the small handle portion 28. Other examples of typical rectal assembly for use with a colonic lavaging machine that include a speculum and an obturator are disclosed in U.S. Pat. No. 4,712,536 to Hawks and U.S. Pat. No. 4,874,363 to Abell.
One problem with the prior art speculum 10 and obturator 25 is that the concentric tube structure and the non-typical shaped obturator structure makes the speculum 10 and obturator 25 more difficult and expensive to manufacture (i.e. usually plastic which requires an injection molding process). Another main problem with the prior art speculum 10 and obturator 25 is that the inlet hose or conduit 110 is attached to the small inlet tube 16 and the outlet hose or conduit 120 is attached to the outlet end 18 after the speculum 10 is inserted and the obturator 25 is removed. The attachment of these hoses or conduits 110 and 120 can be painfill to the patient since the inserting end 17 of speculum 10 can move or slip within the patient's rectum or colon area when the hoses or conduits 110 and 120 are being attached.
A further problem is that after the obturator 25 is removed from the speculum 10 and before the hoses or conduits 110 and 120 are attached, the patient could involuntary excrete fecal matter through the openings and hollow of the speculum 10 (i.e. creating a mess and unsanitary situation). A still further problem that exists with obturators is that they are typically disposed after they are used one time. Since obturators are made of plastic, they can pose an environmental hazard or problem (i.e. they are not biodegradable).
Lubricants or jells have been used to aid the insertion of devices through the rectum or anal canal area. U.S. Pat. No. 3,881,485 to Davis, Jr. ("Davis") discloses a device for insertion through the anus into the upper rectum for the purpose of wiping the walls of the rectum clean of feces and stopping and retaining feces hi the colon and rectum at a distance from the anus. The invention is a preformed fiber device that is shaped for insertion through the anus into the upper rectum. The device is inserted through the anus and up through the rectum with a coating of non-irritating lubricant applied to the wiper plug. The lubricant should preferably be an organic, inert, water soluble jell, but other suitable lubricants may be used.
Other prior art patents disclose colon cleaning systems and methods that introduce enema solution (i.e. preferably with a laxative) into the colon through the anal opening via a suitable tube held in the rectum by an inflated bladder or balloon. The balloon and tube is secured to the patient (i.e. via the anus and to the rectum/colon). U.S. Pat. No. 4,403,982 to Clayton, U.S. Pat. No. 4,406,655 to Clayton, and U.S. Pat. No. 4,842,583 to Majlessi provide examples of such devices. However, these bladder or balloon devices require regulation of the pressure to the bladder or balloon, and they have the problem of the possibility of injury occurring to the patient if the pressure is not regulated properly.
A tip that dissolves in a person used in conjunction with a catheter appears to have been taught. U.S. Pat. No. 5,049,138 to Chevalier et al. ("Chevalier") discloses a catheter having such a dissolvable tip. The catheter includes a flexible tubular member that has an inner lumen and a rigid solid tip disposed at the end of the inner lumen. The tip (i.e. cone shaped) is formed of a material that is slippery when wet, soluble in the bodily fluids and capable of absorbing radiographic fluids that are injected into the inner lumen for identification of the location of X-rays. The solid tip is preferably formed of a water soluble polymer such as polyvinyl alcohol although alternatives are available such as polyethylene oxide, polyethylene glycol, polyacrylamides, polyvinyl pyrolidone, polyacrylic and the like. A narrow passageway is disposed in the tip and extends from the inner lumen to the distal end of the tip. The passageway is adapted to receive a guide wire for insertion of the catheter into an internal organ.
Presently, there does not exist in the prior art or on the market a dissolvable tip that is used in aiding the insertion of a speculum into the anus or rectum/colon area of a patient which is used in conjunction with a colon hydrotherapy speculum system. Therefore, an apparatus and method that is cost effective, environmentally safe and produces no waste hazard or problems, and would allow easy and less painful inserting of a speculum into the rectum or colon area of a person or animal are needed and desired. Also, a dissolvable tip for a colon hydrotherapy speculum system that is used and dissolved entirely within the colon and rectal area of the patient presently does not exist. Furthermore, an apparatus and method of inserting a speculum into the rectum or colon area of a person that is more sanitary (i.e. prevents fecal matter from involuntary excreting when the speculum is inserted) and further helps loosen or break up fecal matter in the colon or rectal area prior to lavaging or washing are also needed and desired.
Additionally, a dissolvable tip for a colon hydrotherapy speculum system that comprises dissolvable material that can deodorize, disinfect, functions as a laxative, or function as a medicine also does not exist. It is an object of the present invention to overcome the problems and limitations of the prior art that have been discussed. It is also another object of the present invention to be able to apply the principles and advantages of this invention to other related applications (i.e. including but not limited to animals).